Abstract
A quantitative, sensitive, and reproducible kinetic turbidimetric adaptation of the Limulus amebocyte lysate (LAL) assay was used to assess endotoxin adsorption/recovery from various types of glass and plastic. Four types of containers, two drying methods, high and low concentrations of two endotoxins, and two elution methods were investigated. The type of container used most profoundly affected recovery, with the best recovery from polystyrene containers and the worst from polypropylene. Adsorption to polypropylene was quite dramatic, with less than 1% recoverable regardless of treatment. A greater percentage of endotoxin was recovered from all containers (except polypropylene) when they were treated with the higher concentration of endotoxin (10,000 vs. 1000 EU per container). Highly purified endotoxin (Novo Pyrexal) was generally more easily recovered from polystyrene and flint glass than Escherichia coli 0113 endotoxin but recovery was about equal for both endotoxins when borosilicate glass was used. This study illustrates the different adsorptive natures of the surfaces tested and provides a guide for controlling depyrogenation validation studies.
- Received April 21, 1986.
- Accepted September 25, 1986.
- Copyright © Parenteral Drug Association. All rights reserved.
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